MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANCED (DOUBLE PACKAGING); CERVICAL ANTERIOR BONE SCREW

Catalog Number 03.30.133

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 16 august 2019: lot 1820905: (b)(4) items manufactured and released on 23-nov-2018.Expiration date: 2023-11-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director: screw fracture in an alif lumbar stabilization few months after surgery.Due to an osteophyte, the optimal position of the cage could not be reached and therefore the mechanics of the compound resulted affected.The most probable cause for the fracture is the suboptimal position of the cage.We cannot determine from the information received if the broken screw is the cause of pain: that is possible, but it's also possible that the failed (or delayed) fusion is the main cause.No reason to suspect a faulty device.Additional implant involved: mectalif anterior 03.30.133 mectalif anterior stand-alone screw diam.5x35 enhanced (double packaging) (k160605) lot.1820443.Batch review performed on 16 august 2019: lot 1820443: (b)(4) items manufactured and released on 28-jun-2018.Expiration date: 2023-05-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.

Event Description

The patient came in complaining of pain due to a screw fracture.During the primary spine surgery, a large anterior osteophyte was present and impeded the cage to be placed all the way posterior towards the back of the vertebral body.The implant was proud anteriorly and not in an ideal position.The patient was also fractured in the anterior superior corner of s1.The patient did not sustain any additional subsidence or instability.The surgeon does not plan on revising the patient at this time, but will monitor the patient.

• Brand Name: MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANCED (DOUBLE PACKAGING)
• Type of Device: CERVICAL ANTERIOR BONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8953728
• MDR Text Key: 216651238
• Report Number: 3005180920-2019-00746
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 07630030875434
• UDI-Public: 07630030875434
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2023
• Device Catalogue Number: 03.30.133
• Device Lot Number: 1820905
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other